Anemia
Conditions
Brief summary
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGmethoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * chronic renal anemia; * regular long-term hemodialysis therapy with the same mode of dialysis for \>=3 months; * continuous iv or sc maintenance ESA treatment during previous 2 months.
Exclusion criteria
* transfusion of red blood cells during previous 2 months; * significant acute or chronic bleeding, such as overt gastrointestinal bleeding; * active malignant disease (except non-melanoma skin cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients maintaining average Hb concentration within target range during evaluation period | Weeks 17-24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range | Weeks 17-24 |
| Dose adjustments; RBC transfusions | Throughout study |
| AEs, laboratory parameters, vital signs | Throughout study |
Countries
Denmark
Outcome results
None listed